Treatment of Agitation/Psychosis in Dementia/Parkinsonism (TAP/DAP)
NCT ID: NCT00043849
Last Updated: 2009-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
60 participants
INTERVENTIONAL
2002-07-31
2005-06-30
Brief Summary
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Detailed Description
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This is a multicenter double-blind, controlled clinical trial in which 60 subjects with a primary dementia (probable Alzheimer's disease \[AD\] or probable dementia with Lewy bodies \[DLB\]) and coexisting parkinsonism, or Parkinson's disease with dementia \[PDD\] will be randomized to 1 of 2 treatment groups: (1) quetiapine (QUET); an atypical antipsychotic with a favorable extrapyramidal side effect profile), or (2) placebo. Each subject participates in the trial for 10 weeks and systematic ratings of behavior, motor function, cognition, adverse events and other outcomes occur at baseline and after 6 and 10 weeks of assigned treatment.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Quetiapine
Eligibility Criteria
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Inclusion Criteria
* Presence of dementia as defined by the Diagnostic and Statistical Manual of Psychiatry, 4th ed. (DSM-IV) American Psychiatric Association. 1994.
* Meets NINDS/ADRDA diagnostic criteria for probable Alzheimer's disease \[AD\] or Consortium diagnostic criteria for probable dementia with Lewy bodies \[DLB\] or diagnostic criteria for Parkinson's disease with dementia \[PDD\].
* Presence of psychosis and/or agitation that interferes with daily activities: a) psychosis, b) hallucination, c) delusion, or d) agitation.
* Presence of 2 or more of the following extrapyramidal motor features: a) resting tremor, b) bradykinesia, c) limb rigidity, d) shuffling, short-stepped gait.
* Sum of ratings for the resting tremor, bradykinesia, rigidity and gait items of the Unified Parkinson's Disease Rating Scale (UPDRS) motor examination component must be greater than or equal to 2.
* Brief Psychiatric Rating Scale (BPRS) score greater than or equal to 12.
* Informed consent by participant or an appropriate proxy.
* Spouse/caregiver who is willing and able to accompany the subject to all clinic visits.
* A stable dosage of non-excluded medications for at least 2 weeks prior to the Screening Visit.
* Is in a stable medical condition for at least 4 weeks prior to the Screening Visit.
* Physically acceptable for this study as confirmed by medical history, physical exam and clinical laboratory tests.
* Must be able to ingest oral medications.
* Supervision must be available for administration of study medication.
* Taking any marketed cholinesterase inhibitor (donepezil \[Aricept\], rivastigmine \[Exelon\], galantamine \[Reminyl\], tacrine \[Cognex\], and/or memantine at a dose unchanged for at least 2 weeks prior to the screening visit.
* Participants may reside in their own home or in a supervised care setting, such as a nursing home.
Exclusion Criteria
* Use of any of the following in the 3 weeks prior to the screening visit: (a) a neuroleptic or atypical antipsychotic medication; or (b) an anticholinergic drug, amantadine for the treatment of parkinsonism \[treatment with levodopa (Sinemet, Sinemet CR) and any dopamine agonist, selegiline or entacapone is allowed\].
* A history of a severe adverse reaction to any antipsychotic medication.
* A serious medical illness that would preclude the safe administration of quetiapine, including active cancer. Skin tumors other than malignant melanoma are not exclusionary. Patients with stable prostate cancer may be included at the discretion of the Program Director.
* Current evidence or history in the last 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness and/or immediate confusion after the injury.
* Known pregnancy.
Excluded Medications During the Study:
* Any classical neuroleptic antipsychotic, such as haloperidol (Haldol).
* Any atypical antipsychotic, such as risperidone (Risperidal), quetiapine (Seroquel), ziprasidone (Geodon), olanzapine (Zyprexa) and clozapine (Clozaril).
* Any anxiolytic other than lorazepam (Ativan), as described above. This includes clonazepam (Klonopin), diazepam (Valium), oxazepam (Serax), clorazepate (Tranxene), buspirone (Buspar) and hydroxyzine (Vistaril).
* Any hypnotic other than lorazepam (Ativan), as described above. This includes estazolam (Prosom), flurazepam (Dalmane), quazepam (Doral), temazepam (Restoril), triazolam (Halcion), diphenhydramine (Benadryl), doxylamine (Unisom), zolpidem (Ambien), zaleplon (Sonata) and chloral hydrate.
50 Years
ALL
No
Sponsors
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National Institute on Aging (NIA)
NIH
Principal Investigators
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Roger Kurlan, MD
Role: PRINCIPAL_INVESTIGATOR
University of Rochester Medical Center, Department of Neurology
Locations
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University of Alabama at Birmingham, Alzheimer's Disease Research Center
Birmingham, Alabama, United States
University of California, San Diego, Alzheimer's Disease Center
La Jolla, California, United States
VA Healthcare System Long Beach
Long Beach, California, United States
University of California at Los Angeles, Alzheimer's Disease Center
Los Angeles, California, United States
Stanford/VA Aging Clinical Research Center, Department of Psychiatry & Behavioral Sciences
Palo Alto, California, United States
Emory University, Alzheimer's Disease Center
Atlanta, Georgia, United States
Medical College of Georgia
Augusta, Georgia, United States
Rush University Medical Center
Chicago, Illinois, United States
Southern Illinois University, School of Medicine
Springfield, Illinois, United States
E. N. Rogers Memorial Veterans Hospital
Bedford, Massachusetts, United States
University of Nevada
Las Vegas, Nevada, United States
Parkinson's Disease and Movement Disorders Center, Albany Medical College
Albany, New York, United States
Maimonides Medical Center
Brooklyn, New York, United States
Columbia University, Alzheimer's Disease Research Center
New York, New York, United States
University of Rochester Medical Center, Alzheimer's Disease Center
Rochester, New York, United States
Syracuse VA Medical Center
Syracuse, New York, United States
University of Pittsburgh, Alzheimer's Disease Research Center
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center at Dallas, Alzheimer's Disease Center
Dallas, Texas, United States
Memory Clinic at Southwestern Vermont Medical Center
Bennington, Vermont, United States
Fletcher Allan Health Care, Inc.
Burlington, Vermont, United States
University of Washington at Seattle, Alzheimer's Disease Research Center
Seattle, Washington, United States
Countries
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References
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Cummings JL, Knopman D. Advances in the treatment of behavioral disturbances in Alzheimer's disease. Neurology. 1999 Sep 22;53(5):899-901. doi: 10.1212/wnl.53.5.899. No abstract available.
Ballard C, Grace J, McKeith I, Holmes C. Neuroleptic sensitivity in dementia with Lewy bodies and Alzheimer's disease. Lancet. 1998 Apr 4;351(9108):1032-3. doi: 10.1016/s0140-6736(05)78999-6. No abstract available.
McManus DQ, Arvanitis LA, Kowalcyk BB. Quetiapine, a novel antipsychotic: experience in elderly patients with psychotic disorders. Seroquel Trial 48 Study Group. J Clin Psychiatry. 1999 May;60(5):292-8.
Other Identifiers
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IA0034
Identifier Type: -
Identifier Source: org_study_id